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| Sponsor: | University Hospital Case Medical Center |
|---|---|
| Collaborators: |
Case Western Reserve University MetroHealth Medical Center National Institutes of Health (NIH) |
| Information provided by: | University Hospital Case Medical Center |
| ClinicalTrials.gov Identifier: | NCT00921297 |
Purpose
Two very common aging-related diseases in older adults are Alzheimer's disease (AD) and cataracts. In elderly adults, these two diseases frequently occur in the same person. Although a cure for AD is currently unavailable, cataracts can be effectively treated with surgery in most people. The removal of cataracts has documented benefits for visual performance and for reducing accidents and falls. However, it has been the experience of the ophthalmologists, and others in the field, that patients, caregivers, and primary care doctors are reluctant to proceed with cataract surgery once an individual is given the diagnosis of AD. It is thought that cataract surgery will not improve the AD patient's quality of life, vision, and cognition. The investigators have designed this study to determine whether or not this is true.
| Condition | Intervention |
|---|---|
|
Cataracts Alzheimer's Disease |
Procedure: Immediate Cataract Surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Therapeutic Effects of Cataract Removal in Alzheimer's Disease |
| Estimated Enrollment: | 210 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Immediate Cataract Surgery
Subjects randomly selected into the Immediate Surgery group will have their cataract surgery scheduled one month from the time their initial study visits are completed. The subjects will be followed monthly for a period of 6 months for surgical and non-surgical adverse events. At the 6-month point, subjects will receive a final comprehensive eye exam and neuropsychological testing. The research partners will complete final activities of daily living and resource utilization questionnaires.
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Procedure: Immediate Cataract Surgery
Cataract surgery, as part of standard of care, will be performed on 1/2 of the group under investigation.
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No Intervention: Delayed Cataract Surgery
Subjects selected into the Delayed Surgery group will be asked to delay their surgery for 6 months after their initial study visits. At 6 months, this group will also undergo the same testing as the Surgery Group.
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In this project, we propose to test the following clinical hypothesis, while addressing the primary and two secondary Specific Aims:
Hypothesis: Cataract removal produces measurable benefits in vision, perception, independent function, and quality of life in patients with co-morbid Alzheimer's disease.
Primary Specific Aim: To determine the effects of cataract removal on visual acuity, spatial contrast sensitivity, vision dependent functions, visual information processing, and quality of life in patients with Alzheimer's disease.
Secondary Specific Aims.
The study is designed as a Randomized Controlled Trial (RCT) with two cohorts of AD patients in a longitudinal investigation. Each person will be evaluated periodically over a 6 month period. All participants will be diagnosed with visually significant bilateral cataractous lens. The cohorts will be established by randomly assigning patients to either the immediate or the (optional) delayed surgery group. Patients will be stratified by AD severity (CDR mild or moderate) and cataract severity prior to being randomized. Comparisons between and within groups will test the change over time in vision, visual information processing, and quality of life associated with or without the removal of cataracts. The RNFL thickness of each person will be evaluated with optical coherence tomography (OCT). The thickness of the RNFL will be compared across dementia severity levels. Each consented participant will have a consenting study partner who may be referred to as a Research Partner, and who will often be the participant's caregiver. The latter will help to assure protocol adherence by the AD participants and will provide information about behavioral symptoms, activities of daily living, and amount of resources used. The study will demonstrate the clinical efficacy of cataract removal as a direct intervention to potentially improve the visual and cognitive functions, and the quality of life in persons diagnosed with AD.
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tatiana M. Riedel, BA | 216-368-6465 | tatiana.majer@case.edu |
| United States, Ohio | |
| University Hospitals Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Jonathan Lass, M.D. 216-844-8588 jonathan.lass@uhhospitals.org | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Thomas Steinemann, M.D. 216-778-2236 tsteinemann@metrohealth.org | |
| Principal Investigator: | Grover C. Gilmore, PhD. | Case Western Reserve University |
| Study Director: | Sara Debanne, PhD. | Case Western Reserve University |
| Study Director: | Julie Belkin, M.D. | University Hospitals Case Medical Center |
| Study Director: | Jonathan Lass, M.D. | University Hospitals Case Medical Center |
| Study Director: | Alan Lerner, M.D. | University Hospitals Case Medical Center |
| Study Director: | Thomas Steinemann, M.D. | MetroHealth Medical Center |
More Information
| Responsible Party: | Grover C. Gilmore, PhD., Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00921297 History of Changes |
| Other Study ID Numbers: | 04-09-21, 1R01AG030114 |
| Study First Received: | June 15, 2009 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Alzheimer's Disease vision impairment cataract quality of life retinal nerve fiber layer |
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Alzheimer Disease Cataract Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Lens Diseases Eye Diseases |